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What is PREZCOBIX® used for?

PREZCOBIX® is a prescription HIV-1 (Human Immunodeficiency Virus 1) medicine always used with other antiretroviral medicines to treat HIV-1 infection in adults. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome). PREZCOBIX® contains prescription medicines PREZISTA® (darunavir) and TYBOST® (cobicistat). PREZCOBIX® does not cure HIV-1 infection or AIDS. You must keep taking HIV-1 medicines to control HIV-1 infection and decrease HIV-related illnesses. PREZCOBIX® should be taken once daily with food.

Important Safety Information

What is the most important information I should know about PREZCOBIX®?

  • PREZCOBIX® may cause liver problems which may be life-threatening. Tell your healthcare provider right away if you have any symptoms such as: 
    • Dark (tea-colored) urine
    • Yellowing of your skin or the whites of your eyes
    • Pale-colored stools (bowel movements)
    • Nausea
    • Vomiting
    • Pain or tenderness on your right side below your ribs
    • Loss of appetite
  • PREZCOBIX® may cause severe or life-threatening skin reactions or rashesStop taking PREZCOBIX® and call your healthcare provider right away if you develop any skin changes with symptoms below: 
    • Fever
    • Tiredness
    • Muscle or joint pain
    • Blisters or skin lesions
    • Mouth sores or ulcers
    • Red or inflamed eyes, like "pink eye" (conjunctivitis)
  • PREZCOBIX®, when taken with some other medications, can cause new or worse kidney problems, including kidney failure. 

Who should not take PREZCOBIX®?

  • Do not take PREZCOBIX® with any of the following medicines: alfuzosin, carbamazepine, cisapride, colchicine (if you have liver or kidney problems), dronedarone, elbasvir and grazoprevir, dihydroergotamine, ergotamine tartrate, lovastatin or a product that contains lovastatin, lurasidone, methylergonovine, oral midazolam, phenobarbital, phenytoin, pimozide, ranolazine, rifampin, sildenafil when used for pulmonary arterial hypertension (PAH), simvastatin or a product that contains simvastatin, St. John’s Wort (Hypericum perforatum) or a product that contains St. John’s Wort, or triazolam.
  • Serious problems can happen if you take any of these medicines with PREZCOBIX®.

What should I tell my healthcare provider before taking PREZCOBIX®?

Tell your healthcare provider if you:

  • have liver problems, including hepatitis B or hepatitis C, have kidney problems, are allergic to sulfa (sulfonamide), have diabetes, have hemophilia, or have any other medical condition
  • are pregnant, or plan to become pregnant. PREZCOBIX® should not be used in pregnant women because you may not have enough PREZCOBIX® in your body during pregnancy. Your healthcare provider will prescribe different medicines if you become pregnant while taking PREZCOBIX®. It is unknown if PREZCOBIX® will harm your unborn baby.
  • are breastfeeding, or plan to breastfeed. You should not breastfeed if you have HIV-1 because of the risk of passing HIV to your baby. It is unknown if PREZCOBIX® can pass into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines interact with PREZCOBIX®. Keep a list of your medicines to show your healthcare provider and pharmacist.

Do not start taking a new medicine without telling your healthcare provider.

What are the possible side effects of PREZCOBIX®?

PREZCOBIX® may cause serious side effects including:

  • Diabetes and high blood sugar
  • Changes in body fat can happen in people taking HIV-1 medications
  • Immune system changes can happen in people who start HIV medications
  • Increased bleeding can occur in people with hemophilia who are taking PREZCOBIX® 

The most common side effects are:

  • Diarrhea
  • Nausea
  • Rash
  • Headache
  • Stomach area (abdominal) pain
  • Vomiting

These are not all the possible side effects of PREZCOBIX®. Tell your healthcare provider if any side effect bothers you or does not go away. For more information, ask your healthcare provider.

You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.fda.gov/medwatch or call 1-800-FDA-1088

You may also report side effects to Janssen Products, LP at 1-800-JANSSEN (1-800-526-7736).

Please read full Product Information for PREZCOBIX® for more details.

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